UK MHRA Guidance: Medicines: How to Reclassify your Product
Swiss Medic Guidance: Authorisation Procedures for Covid-19 Medicinal products
USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
MALAYSIAN (NPRA): VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS
EMA Guidance: Prevention of Medicine Shortages in the EU
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements
SwissMedic updated Guidance: Packaging for Human Medicinal Products
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
USFDA's Draft Guidance: Orange Book Questions and Answers
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A
UK MHRA's -Updated Guidance: How to Apply for Authorisation in the UK
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
SFDA's Guidance on Data Requirements for the Renewal of Marketing Authorizations Drug Products
India MoH's - Draft Proposal for adding QR Codes for important SCHEDULE H2 Drugs
South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction
Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration
ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation